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Use of Pancreatic Enzymes in Short Bowel Syndrome (SBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03097029
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : February 10, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
Patients with short bowel syndrome have a high mortality rate that is mainly attributed to complications from central lines and long-term intravenous (IV) nutrition. There are few medical therapies to date that improve gut absorption in patients with short bowel syndrome. The primary objective of this study is to evaluate if absorption from the GI tract improves in subjects with short bowel syndrome following therapy with pancreatic enzymes.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Pancreatic Enzyme Phase 2

Detailed Description:
This is an interventional study of subjects with short bowel syndrome to determine if enteral absorption improves following therapy with pancreatic enzymes. The study will assess enteral absorption and nutritional status at baseline through a series of stool tests, blood tests, and anthropometric measurements. Following approximately ten days of therapy with pancreatic enzymes, the study will reassess enteral absorption.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Pancreatic Enzymes in Short Bowel Syndrome
Actual Study Start Date : March 24, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pancreatic Enzymes
All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.
Drug: Pancreatic Enzyme
All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
Other Name: Creon




Primary Outcome Measures :
  1. Change in Coefficient of Fat Absorption [ Time Frame: Up to 10 days ]
    Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.


Secondary Outcome Measures :
  1. Change in the Coefficient of Nitrogen Absorption [ Time Frame: Up to 10 days ]
    Coefficient of nitrogen absorption (CNA) measures the amount of nitrogen excreted in the stool compared to how much nitrogen was consumed in a 72 hour period. This is a measure of protein absorption. CNA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CNA values at each timepoint was a study outcome.


Other Outcome Measures:
  1. Change in Malabsorption Blood Test [ Time Frame: Up to 10 days ]
    This test will only be performed on subjects 18 years or older. This an isotope test. Subjects consume a high fat shake with two labeled fats. They have blood tests measured at baseline and then every 1 hour for 8 hours to check for serum levels of labeled fats. This helps determine how well the labeled fats are being absorbed by the intestine.



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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of a small bowel resection with subsequent dependence on parenteral nutrition for at least three months
  • age 4 years to 65 years
  • usual state of health for the past two weeks with no medication changes
  • able to participate in a study for about four weeks with four study visits
  • able to take pancreatic enzyme medication orally

Exclusion Criteria:

  • significant disease other than short bowel syndrome affecting the gastrointestinal tract that impacts absorption or digestions
  • motility disorder
  • medications that directly alter fat absorption
  • cholestatic liver disease defined as a serum conjugated bilirubin greater than 1.0 mg/dL, chronic renal failure, gout, or hyperuricemia
  • history of a pork allergy
  • women who are pregnant or lactating
  • history of fibrosing colonopathy

Those subjects who are eligible for the malabsorption blood test (MBT) test will be excluded if they have a history of a soy or safflower oil allergy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097029


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
AbbVie
Investigators
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Principal Investigator: Natalie Terry, MD, PhD Children's Hospital of Philadelphia
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03097029    
Other Study ID Numbers: 16-013255
First Posted: March 31, 2017    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
pancreatic enzymes
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications